Jakarta, CNN Indonesia –
National Agency of Drug and Food Control (BPOM) describes the findings of the study and inspection results in phase I clinical trials archipelago vaccines initiated by the former health minister Terawan Agus Putranto. The findings also made BPOM fail to grant approval for the Implementation of Clinical Trials (PPUK) for phase II clinical trials.
Head of BPOM, Penny K. Lukito, also highlighted the concept of an archipelago vaccine which was claimed to be the work of the nation’s children, but there were several oddities. Starting from the research team which is dominated by foreigners, to the components of the manufacture of dendritic cell vaccines, most of which are obtained from expensive imported components.
“In the results of the clinical trial of vaccine I, the discussion is a team of foreign researchers who explain, defend and discuss, process, when we hearing. And it is proven that the clinical trial implementation process, the production process is all carried out by the foreign research team, “explained Penny in a hearing with Commission IX of the Indonesian House of Representatives which was broadcast online, Thursday (8/4).
Penny explained that the foreign research team was a member of the sponsor of AIVITA Biomedical from the United States. He also revealed that the Diponegoro University research team and dr. Kariadi Semarang did not have much to do with the clinical trial process I for this archipelago vaccine.
“There is training the doctors at Kariadi Hospital, but then they just watched, didn’t do it directly, because they also didn’t control the question, “he added.
Penny admitted that his party found many irregularities during the data validation process. So that BPOM does not give the green light because the national vaccine is considered not passing the research rules and ethics.
He said, the components used in phase I clinical trial research were actually not suitable for entering the human body, because the components were not included in pharmaceutical grade.
“That there are components that are really imported components and they are not cheap, plus there is another one, when the examination is done, it is found that the antigens used are not of quality quality to enter the human body,” explained Penny.
In addition, the concept of dendritic vaccination will be carried out in the open, even though activities that use dendritics should be carried out sterile and closed.
Because, how it works, each person will be taken a blood sample and then exposed to a vaccine kit formed from dendritic cells. Then the cells that have recognized the antigen will be incubated for 3-7 days.
The result will then be injected back into the body. In the body, these dendritic cells are expected to trigger other immune cells to form a memory defense system against Sars Cov-2.
“This means that there must be a series of validations that prove that the product before being put into the subject is completely sterile, uncontaminated, and it is not fulfilled,” he concluded.
At the end of March, the domestic vaccine research process was temporarily halted. Vaccination spokesperson for the Ministry of Health, Siti Nadia Tarmizi, said that the temporary suspension was carried out because the research team wanted to complete the Good Manufacturing Practices (CPOB) document so that BPOM could grant permission for phase II clinical trials.